With the next two compliance dates for the Drug Supply Chain Security Act (DSCSA) approaching, pharma industry professionals need to make important decisions related to serialization and the exchange of transaction level data. Through the GS1 Healthcare US industry initiative, the pharmaceutical industry is exploring the use of the global GS1 and ISO standard called the Electronic Product Code Information Services (EPCIS) to help meet both the immediate and long-term requirements of DSCSA.
EPCIS has been supported by the Food and Drug Administration as a communication method for reporting transactional information and provides the data attributes and message structure needed to comply with the information handling and retrieval provisions of the DSCSA. Still, some companies are unaware of this standard’s many benefits. Let’s explore EPCIS and why and how it can be implemented to address regulatory requirements:
1. EPCIS works with standards many pharma companies are already using.
EPCIS works within the GS1 System of Standards, which is likely to already be a part of the industry’s existing product identification and information sharing processes. GS1 identifiers like Global Trade Item Numbers (GTINs) and Global Location Numbers (GLNs) play a foundational role in uniquely identifying a product and the place it was manufactured. GTINs specifically describe products and GLNs provide unique location information for each product in the pharma supply chain. They are essentially the pieces of information about pharmaceuticals, logistics units and other assets in the supply chain that flow between trading partners via EPCIS.
2. EPCIS is versatile.
With its extreme scalability and versatility, EPCIS allows for healthcare industry-specific enhancements to be implemented using a number of GS1 barcodes and data carriers. EPCIS also allows companies to share master data imbedded in the event or document, or through a query mechanism. In addition, EPCIS is the only global standard. Leveraging standards to meet specific geographic or market needs helps trading partners to achieve regulatory compliance and improve global supply chain efficiency.
3. Successful pilot programs are being reported.
There are many trading partner pilots underway this year that leverage EPCIS according to industry recommendations for adoption. Recently, an industry solution provider announced the completion of a successful EPCIS pilot program conducted with a top pharmaceutical manufacturer and top wholesale distributor. The pilot program was designed to test real-world scenarios, managing the preparation, exchange and verification of serialized product information in a production environment for commercial product. They reported high operational speed and maintenance of a high level of efficiency in the processing of thousands of serialized units.
Since late 2014, the industry has been leveraging the GS1 US guideline “Applying GS1 Standards to U.S. Pharmaceutical Supply Chain Business Processes to Support the Drug Supply Chain Security Act.” This guidance was developed in collaboration with more than 160 GS1 Healthcare US initiative members prior to the first DSCSA deadline. An updated version is expected to be published later this year.
4. EPCIS helps a company collaborate long term with different supply chain partners.
It is beneficial to think of EPCIS adoption beyond simply meeting the compliance date, as the ROI is significant over the long term as well. According to a recent Acsis survey, researchers cautioned manufacturers taking a “compliance now” approach that they may get caught with long-term costs and rework of initiatives to build a truly traceable warehouse. In general, the implementation of standards, including EPCIS, can protect brands from risk in a variety of ways, such as providing improved recall readiness, and the ability to document chain of custody, minimizing opportunities for counterfeit drugs to circulate through the supply chain. By failing to recognize the long-term implications, companies can risk lowering productivity by adding additional manual processes.
Ultimately, with lot-level management compliance already underway, now is the time for healthcare organizations to update business processes and information systems in order to move the pharmaceutical industry forward into the next chapter of efficiency and growth. Through collaborative processes such as EPCIS adoption, manufacturers and other industry stakeholders can continue their transition to a safer, automated and serialized supply chain.
In November 2013, the President signed into law the Drug Quality and Security Act (DQSA) (H.R. 3204). The DQSA is the result of a multi-year effort to produce balanced legislation taking into consideration stakeholder priorities. Factors include California delegation concerns with pre-emption, the FDA’s desire to preserve “pedigree” and get to a more robust, more transparent track-and-trace, while preserving Constitutional 10th Amendment rights. Implicit within the DQSA is the Drug Supply Chain Security Act (DSCSA), which outlines critical steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the U.S.
While there has been general agreement among all states within the United States regarding the need to address drug security, there have been differing opinions regarding how best to address the issue. The result has been 50 separate states’ specific legislations all trying to address the same basic supply chain. The passage of DQSA supersedes each individual state’s specific legislation, creating a single unified federal framework to address supply chain security.
This new federal legislation results in an immediate preemption of all state laws, regulations and requirements for tracing products through the supply chain, including any recordkeeping and pedigree requirements. It also states that the current federal pedigree requirements as defined under the Prescription Drug and Marketing Act (1987) continued in force until Jan. 1, 2015, and served as a bridge to the new national framework.
The implementation of the act is phased:
Phase 1: Lot-Level Management
Started Jan. 1, 2015, for manufacturers, wholesalers and repackagers; and July 1, 2015, for pharmacy (hospitals and retail): Share the 3T’s – Transaction Information (TI), History (TH) and Statements (TS) at the lot (or batch) level of identification.
Phase 2: Item Serialization Mid-Term (2017 – 2019)
Manufacturer/repackagers serialize packages of drug products using a product identifier (GS1 global trade item number (GTIN) or NDC), serial number, lot number and expiration date.
Phase 3: Serialized Item-Level Traceability
By November 2023, make available information that would allow supply chain partners to trace the ownership back to the initial manufacturer or repackager.
Information courtesy of Bikash Chatterjee, president, Pharmatech Associates and GS1 US